Medical Device Manufacturer · US , Naples , FL

Arthrex, Inc. - FDA 510(k) Cleared Devices

357 submissions · 353 cleared · Since 1992
357
Total
353
Cleared
0
Denied
318 devices
176-200 of 318
Cleared Sep 03, 2014
ARTHREX IBALANCE TKA SYSTEM
K141635 · MBH
Orthopedic · 76d
Cleared Aug 15, 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735 · HRS
Orthopedic · 49d
Cleared Aug 13, 2014
ARTHREX FIBERTAK SUTURE ANCHOR
K140476 · MBI
Orthopedic · 168d
Cleared Jul 18, 2014
ARTHREX PIP DART
K141577 · HTY
Orthopedic · 35d
Cleared Jul 08, 2014
ARTHREX FRACTURE PLATES AND SCREWS
K141478 · HRS
Orthopedic · 34d
Cleared Mar 10, 2014
CMC MINI TIGHTROPE
K140328 · HTN
Orthopedic · 28d
Cleared Feb 27, 2014
ARTHREX IBALANCE TKA SYSTEM
K133854 · JWH
Orthopedic · 70d
Cleared Jan 30, 2014
MINI TIGHTROPE
K133275 · HTN
Orthopedic · 98d
Cleared Dec 17, 2013
ARTHREX IBALANCE TKA SYSTEM
K133342 · JWH
Orthopedic · 48d
Cleared Nov 25, 2013
ARTHREX COMPRESSION FT SCREWS
K132217 · HWC
Orthopedic · 131d
Cleared Oct 30, 2013
ARTHREX UNIVERS II CA HEADS
K130675 · HSD
Orthopedic · 231d
Cleared Sep 27, 2013
ARTHREX UNIVERS APEX
K131633 · KWS
Orthopedic · 115d
Cleared Sep 25, 2013
ARTHREX COMPRESSION PLATES
K130510 · HRS
Orthopedic · 210d
Cleared Jul 03, 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474 · HRS
Orthopedic · 42d
Cleared May 31, 2013
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
K130129 · KWS
Orthopedic · 134d
Cleared May 03, 2013
KNOTLESS FIBERTAK SUTURE ANCHOR
K130458 · MBI
Orthopedic · 70d
Cleared Apr 05, 2013
ARTHREX FRACTURE PLATES
K123241 · HRS
Orthopedic · 170d
Cleared Dec 21, 2012
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON,...
K123341 · MBI
Orthopedic · 51d
Cleared Mar 20, 2012
BIOBOLT
K120540 · MAI
Orthopedic · 26d
Cleared Mar 08, 2012
ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED
K120044 · KWS
Orthopedic · 63d
Cleared Feb 17, 2012
ARTHREX KNOTLESS SUTURETAK ANCHOR
K120155 · MBI
Orthopedic · 30d
Cleared Dec 21, 2011
ARTHREX FRACTURE SYSTEM
K112437 · HTN
Orthopedic · 119d
Cleared Dec 19, 2011
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
K112990 · HTY
Orthopedic · 74d
Cleared Dec 15, 2011
ARTHREX BIOCOMPOSITE TRANSFIX
K112040 · MAI
Orthopedic · 150d
Cleared Sep 02, 2011
MICROSUTURE ANCHORS
K112237 · HWC
Orthopedic · 29d

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